NCT07017972

Data Collection and Professional Simulated Use Study to Develop an Embryo Quality Artificial Intelligence (AI) Model

Multicenter Data Collection and Simulated-Use Assessment for CHLOE

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: Fairtility · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This protocol supports the reliable development and improvement of Artificial Intelligence (AI)-based applications by enabling training, verification, and validation using high-quality real clinical data. It also aims to enhance machine learning in developmental-use AI software. In addition, the professional user simulated use will ensure correct and easy use of the AI applications.

Detailed description

This data collection protocol aims to allow the reliable and robust development (training, verification, and validations) of Artificial Intelligence (AI) technology-based applications as well as improving the machine learning stage of released devices/applications - an AI - based software, for developmental use only, through inspection of large body of high quality real clinical data. Another important element in the design of the application is the user interface. It is thus important to run simulated use assessments to ensure correct and easy use of the AI application by professional users.

Conditions

• Fertility Disorders

Interventions

Type	Name	Description
DEVICE	AI evaluation of embryos	AI evaluation of embryos inside a time-lapse incubator.

Timeline

• Start date: 2025-06-20
• Primary completion: 2027-06-20
• Completion: 2027-06-20
• First posted: 2025-06-12
• Last updated: 2025-08-07

Locations

1 site across 1 country: United States